AMOXIL CAPSULES 250 MG

Main information

  • Trade name:
  • AMOXIL CAPSULES 250 MG
  • Dosage:
  • 250mg Milligram
  • Pharmaceutical form:
  • Capsule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AMOXIL CAPSULES 250 MG
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1077/033/001
  • Authorization date:
  • 01-04-2002
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995,asamended

MedicinalProducts(ControlofPlacingontheMarket)Regulations,2007,asamended

PA1077/033/001

CaseNo:2084980

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

GlaxoSmithKline(Ireland)Limited

StonemasonsWay,Rathfarnham,Dublin16,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

AmoxilCapsules250mg.

theparticularsofwhicharesetoutintheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsasmaybespecifiedin

thesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom30/06/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 30/06/2010 CRN 2084980 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AmoxilCapsules250mg.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachcapsulecontains250mgamoxicillin(astrihydrate).

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Capsule,hard.(capsule)

Maroonandgoldcapsuleswith‘GSLEX'printedinwhiteonthecapandbody,containingawhitepowder.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Inthetreatmentofinfectionsduetoorganismssensitivetoamoxicillin.

`Amoxil`isabroadspectrumantibiotic,indicatedforthetreatmentofcommonlyoccurringbacterialinfectionssuchas:

Upperrespiratorytractinfections

Otitismedia

Acuteandchronicbronchitis

Lobarandbronchopneumonia

Cystitis,urethritis,pylelonephritis

Bacteriuriainpregnancy

Gynaecologicalinfectionsincludingpuerperalsepsisandsepticabortion

Acuteuncomplicatedgonorrhoea

Peritonitis

Intra-abdominalsepsis

Septicaemia

Bacterialendocarditis

Typhoidandparatyphoidfever

Skinandsofttissueinfections

Dentalabscess(asadjuncttosurgicalmanagement)

Inchildrenwithurinarytractinfection,theneedforinvestigationshouldbeconsidered.

Parenteraltherapyisindicatediftheoralrouteisconsideredimpracticableorunsuitableandparticularlyfortheurgent

treatmentofsevereepisodesoftheaboveconditions.

Prophylaxisofendocarditis

`Amoxil`maybeusedforthepreventionofbacteraemia,associatedwiththeproceduressuchasdentalextraction,in

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4.2Posologyandmethodofadministration

RouteofAdministration:oral

Theabsorptionof‘Amoxil’isvirtuallyunimpairedbythepresenceoffood.

Standardadultdosage:Theusualdailydosageis750mgindivideddoses(i.e.250mgthreetimesdailybytheoral

route).

Incasesofsevereinfectionthedosagemaybedoubled,or‘Amoxil’givenbyinjection.

Highdosagetherapy(maximumrecommendedoraldosageof6gdailyindivideddoses):Adosageof3gtwicedaily

isrecommendedinappropriatecasesforthetreatmentofsevereorrecurrentpurulentinfectionoftherespiratorytract.

Shortcoursetherapy:Simpleacuteurinarytractinfection:two3gdoseswith10-12hoursbetweenthedoses.

Gonorrhoea:3gasasingledose

Dentalabscess:two3gdoseswitheighthoursbetweenthedoses.

Childrenupto10yearsofage:Theusualtotaldailydosageis375mgindivideddoses(i.e.125mgthreetimesdaily

bytheoralroute).

Insevereorrecurrentacuteotitismedia,especiallywherecompliancemaybeaproblem,750mgtwiceadayfortwo

daysmaybeusedasanalternativecourseoftreatmentinchildrenaged3to10years.

ProphylaxisofEndocarditis:

Fordentalprocedureswhereanoraldoseisappropriate:

Adults:3g‘Amoxil’orally,1hourbeforeprocedure.Aseconddosemaybegiven6hourslater,ifconsidered

necessary.

Children: Aged5-10:Halftheadultdose(i.e.1.5ggivenasasingle60mldoseof‘Amoxil’Syrup(125mg/5ml).

Under5:Quarteradultdose.

Renalimpairment:Inrenalimpairmenttheexcretionofantibioticwillbedelayedanddependingonthedegreeof

impairmentitmaybenecessarytoreducethetotaldailydosage.

AmoxicillinPaediatricSuspensionisrecommendedforchildrenunder6monthsofage.

Inpatientsreceivingperitonealdialysis:

Glomerularfiltrationrate

Adults Oraltreatment

>30ml/min Noadjustmentnecessary

10-30ml/min Amox.Max500mgb.d.

<10ml/min Amox.Max500mg/day

Childrenunder40kg Oraltreatment

>30ml/min Noadjustmentnecessary

10-30ml/min 15mg/kggivenb.i.d.

(maximum500mg/twicedaily)

<10ml/min 15mg/kggivenasasingledaydose

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Amoxicillinmayberemovedfromthecirculationbehaemodialysis.

4.3Contraindications

Useinpatientswithahistoryofhypersensitivitytobeta-lactamantibioticsincludingpenicillinsorcephalosporins.

4.4Specialwarningsandprecautionsforuse

Beforeinitiatingtherapywithamoxicillin,carefulenquiryshouldbemadeconcerningprevioushypersensitivity

reactionstopenicillins,cephalosporins.Cross-sensitivitybetweenpenicillinsandcephalosporinsiswelldocumented.

Seriousandoccasionallyfatalhypersensitivityreactions(anaphylaxis)havebeenreportedinpatientsreceivingbeta-

lactamantibiotics.Ifanallergicreactionoccurs,amoxicillinshouldbediscontinuedandappropriatealternativetherapy

instituted.

Amoxicillinshouldbeavoidedifinfectionsmononucleosis(glandularfever)issuspectedsincetheoccurrenceofa

morbilliformrashhasbeenassociatedwiththisconditionfollowingtheuseofamoxicillin.

Prolongeduseofananti-infectivemayoccasionallyresultinovergrowthofnon-susceptibleorganisms.

Abnormalprolongationofprothrombintime(increasedINR)hasbeenreportedrarelyinpatientsreceivingamoxicillin

andoralanticoagulants.Appropriatemonitoringshouldbeundertakenwhenanticoagulantsareprescribed

concurrently.Adjustmentsinthedoseoforalanticoagulantsmaybenecessarytomaintainthedesiredlevelof

anticoagulation.

Dosageshouldbeadjustedinpatientswithrenalimpairment(seeSection4.2).

Inpatientswithreducedurineoutputcrystalluriahasbeenobservedveryrarelypredominantlywithparenteraltherapy.

Duringtheadministrationofhighdosesofamoxicillin,itisadvisabletomaintainadequatefluidintakeandurinary

outputinordertoreducethepossibilityofamoxicillincrystalluria.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Probeneciddecreasestherenaltubularexcretionofamoxicillin.Concurrentusewithamoxicillinmayresultin

increasedandprolongedbloodlevelsofamoxicillin.

Concurrentadministrationofallopurinolduringtreatmentwithamoxicillincanincreasethelikelihoodofallergicskin

reactions.

Incommonwithotherantibiotics,amoxicillinmayaffectthegutflora,leadingtoloweroestrogenreabsorptionand

reducedefficacyofcombinedoralcontraceptives.

Intheliteraturetherearerarecasesofincreasedinternationalnormalisedratioinpatientsmaintainedonacenocoumarol

orwarfarinandprescribedacourseofamoxicillin.Ifco-administrationisnecessary,theprothrombintimeor

internationalnormalisedratioshouldbecarefullymonitoredwiththeadditionorwithdrawalofamoxicillin.

4.6Pregnancyandlactation

Useinpregnancy:

Animalstudieswith‘Amoxil’haveshownnoteratogeniceffects.Theproducthasbeeninextensiveclinicalusesince

1972anditssuitabilityinhumanpregnancyhasbeenwelldocumentedinclinicalstudies.

Amoxicillinmaybeusedinpregnancywhenthepotentialbenefitsoutweighthepotentialrisksassociatedwith

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Useinlactation:

Amoxicillinmaybeadministeredduringtheperiodoflactation.Withtheexceptionoftheriskofsensitisation

associatedwiththeexcretionoftracequantitiesofamoxicillininbreastmilk,therearenoknowndetrimentaleffectsfor

theinfant.

4.7Effectsonabilitytodriveandusemachines

Adverseeffectsontheabilitytodriveoroperatemachineryhavenotbeenobserved.

4.8Undesirableeffects

Thefollowingconventionhasbeenutilisedfortheclassificationofundesirableeffects:

Verycommon(morethan1/10),common(morethan1/100,lessthan1/10),uncommon(morethan1/1000,lessthan

1/100),rare(morethan1/10,000,lessthan1/1000),veryrare(lessthan1/10,000).

Themajorityoftheside-effectslistedbelowarenotuniquetoamoxicillinandmayoccurwhenusingotherpenicillins.

Unlessotherwisestated,thefrequencyofadverseevents(AEs)hasbeenderivedfrommorethan30yearsofpost-

marketingreports.

Bloodandlymphaticsystemdisorders

Veryrare: Reversibleleucopenia(includingsevereneutropeniaor

agranulocytosis),reversiblethrombocytopeniaandhaemolytic

anaemia.

Prolongationofbleedingtimeandprothrombintime

Immunesystemdisorders

Veryrare: Aswithotherantibiotics,severeallergicreactions,including

angioneuroticoedema,anaphylaxis(seeWarningsand

Precautions),serumsicknessandhypersensitivityvasculitis.

Ifahypersensitivityreactionisreported,thetreatmentmustbediscontinued.(See

alsoSkinandsubcutaneoustissuedisorders).

Nervoussystemdisorders

Veryrare: Hyperkinesia,dizzinessandconvulsions.Convulsionsmay

occurinpatientswithimpairedrenalfunctionorinthose

receivinghighdoses.

InfectionsandInfestations

Veryrare: Mucocutaneouscandidiasis

Gastrointestinaldisorders

#Common: Diarrhoeaandnausea.

#Uncommon: Vomiting.

Veryrare: Antibioticassociatedcolitis(includingpseudomembraneous

colitisandhaemorrhagiccolitis)

Blackhairytongue

Superficialtoothdiscolourationhasbeenreportedinchildren.

Goodoralhygienemayhelptopreventtoothdiscolourationas

itcanusuallyberemovedbybrushing(forsuspensionand

chewabletabletformulationsonly)

Hepato-biliarydisorders

Veryrare: Hepatitisandcholestaticjaundice.AmoderateriseinAST

and/orALT.

ThesignificanceofariseinASTand/orALTisunclear.

Skinandsubcutaneoustissuedisorders

#Common: Skinrash.

#Uncommon: Urticariaandpruritus.

Veryrare: Skinreactionssuchaserythemamultiforme,Stevens-Johnson

syndrome,toxicepidermalnecrolysis,bullousandexfoliative

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4.9Overdose

Grossoverdosagewillproduceveryhighurinaryconcentrations,moresoafterparenteraladministration.Symptomsof

water/electrolyteimbalanceshouldbetreatedsymptomatically.Problemsareunlikelytooccurifadequatefluidintake

andurinaryoutputaremaintained;however,amoxicillincrystalluriainsomecasesleadingtorenalfailure,hasbeen

observed(seeSection4.4,SpecialWarningsandSpecialPrecautionsforUse).Morespecificmeasuresmaybe

necessaryinpatientswithimpairedrenalfunction:theantibioticisremovedbyhaemodialysis.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

`Amoxil`isabroad-spectrumantibioticwhichpossessesthesafetyprofileofthepenicillinsandisrapidlybactericidal

againstawiderangeofGram-negativeandGram-positiveorganisms.

5.2Pharmacokineticproperties

`Amoxil`iswellabsorbedbytheoralandparenteralroutes,peakbloodlevelsareachievedonetotwohoursafter

administration.Oraladministrationproduceshighserumlevelsindependentofthetimeatwhichthefoodistaken.

`Amoxil`givesgoodpenetrationintothebronchialsecretionsandthehighurinaryconcentrationsofunchanged

antibiotic.Theaverageserumhalflifeis60minutes.Eliminationismainlyviatheurine.

5.3Preclinicalsafetydata

Therearenopre-clinicaldataofrelevancetotheprescriberwhichareadditionaltothatalreadyincludedinother

sectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Magnesiumstearate

Capsuleshell:

Cap:

Gelatin

Erythrosine(E127)

Indigocarmine(E132)

Titaniumdioxide(E171)

Body:

Gelatin

Titaniumdioxide(E171)

Yellowironoxide(E172)

PrintingInk:

Shellac

(AGEP).

(SeealsoImmunesystemdisorders).

RenalandUrinarytractdisorders

Veryrare: Interstitialnephritis,crystalluria(seeOverdosage)

#TheincidenceoftheseAEswasderivedfromclinicalstudiesinvolvingatotalof

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AntifoamDC1510

Titaniumdioxide(E171)

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

Storeintheoriginalcontainer.

6.5Natureandcontentsofcontainer

Polypropylenecontainerswithpolyethylenelidcontaining100or500capsules.PVC/aluminiumfoilblisterpacks

containing3,6,12or21capsules.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

GlaxoSmithKline(Ireland)Limited

StonemasonsWay

Rathfarnham

Dublin16

8MARKETINGAUTHORISATIONNUMBER

PA1077/33/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01April1977

Dateoflastrenewal:01April2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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